Section 18973.4 - Annual Report for Covered DrugsOn or before March 31, 2022, and each year thereafter, a program operator shall prepare and submit an annual report to the department. To be complete, the annual report shall describe how the program operator complied with all elements in its stewardship plan during the previous reporting period of one year, and shall contain the following:
(a) Contact information pursuant to section 18973.2(a), including any changes or updates to this information.(b) Executive Summary. A concise summary of the information contained in the report that includes, but is not limited to, the highlights, outcomes and challenges, achievement of the convenience standards pursuant to subsection (1)(F) of subdivision (a) of section 42032.2 of the Public Resources Code, education and outreach efforts, and ways in which challenges are being addressed.(c) Collection System. Description of the following: (1) How ultimate users had an opportunity to dispose of their covered drug(s) as described in the approved stewardship plan.(2) Efforts between the program operator and potential authorized collectors to establish authorized collection sites, including, but not limited to: (A) Pursuant to section 18973.2(d)(2), efforts to notify potential authorized collectors of the opportunity to serve as an authorized collector for the stewardship program in the counties in which the program operated, and the list of potential authorized collectors that were notified.(B) Pursuant to section 18973.2(d)(3), the process by which good faith negotiations with potential authorized collectors were conducted.(C) Pursuant to section 18973.2(d)(4), efforts to work with retail pharmacies and retail pharmacy chains to fulfill the requirement in section 42032.2(b)(2) of the Public Resources Code, if applicable.(D) Pursuant to section 18973.2(d)(5), efforts to incorporate potential authorized collectors that submitted a written offer to join the stewardship program, and the list of potential authorized collectors that submitted written offers.(E) Pursuant to section 18973.2(d)(6), a list of potential authorized collectors that submitted a written offer to join the stewardship program and were rejected, and the reason(s) for each rejection.(F) Description of how the program operator complied with the requirement in section 18973.2(d)(7).(3) How the convenience standards pursuant to subsection (1)(F) of subdivision (a) of section 42032.2 of the Public Resources Code were met. Include necessary changes to calculations that account for changes in the number of authorized collection sites and most recent publicly available population calculations from the State of California Department of Finance. If the convenience standards were not met, describe efforts made to achieve compliance.(4) For each participating authorized collection site, include the following: (A) Name and physical address(B) Amount of covered drugs collected, as required in the stewardship plan pursuant to section 18973.2(g)(4)(C) Number of instances that collected covered drugs were picked up for disposal(D) Number of receptacle liners picked up for disposal(E) Number of instances and corresponding amount of time the secure collection receptacle was not available to the public during business hours. For each instance, provide a description of why the secure collection receptacle was not available.(5) For each type of mail-back service utilized, include the following, as applicable: (A) List of distribution locations(B) Mechanism(s) of distribution(C) Amount of mail-back materials distributed, as required in the stewardship plan pursuant to section 18973.2(g)(6)(E)(D) Amount of mail-back material returned, as required in the stewardship plan pursuant to section 18973.2(g)(6)(E)(6) For each alternative form of collection and disposal, include the following, as applicable: (A) Method(s) of collection(B) Name and address of location(s)(C) Number of collections(D) Amount of materials distributed, as required in the stewardship plan pursuant to section 18973.2(g)(6)(E)(E) Amount of material collected, as required in the stewardship plan pursuant to section 18973.2(g)(6)(E)(d) Transportation and Disposal System. Description of the methods used for transportation and disposal of covered drugs, including the following: (1) Mechanism(s) for tracking the collection, transportation, and disposal of covered drugs(2) Name and mailing address of each service provider used to transport or process covered drugs(3) For each disposal facility, include the following:(A) Name of disposal facility(B) Mailing and physical address(C) Weight of covered drugs disposed(e) Policies and Procedures. Pursuant to subdivision (b)(6) of section 42033.2 of the Public Resources Code, provide the following: (1) Description of whether policies and procedures for collecting, transporting, and disposing of covered drugs, as established in the stewardship plan, were followed during the reporting period(2) Description of each instance of noncompliance from stewardship plan policies and procedures, if any occurred(3) Corrective actions taken, or that will be taken, if the program operator discovered critical instances of noncompliance with stewardship plan policies and procedures(f) Description of updates, that have been made or will be made, to the processes and policies followed to safely and securely collect, track, and properly manage covered drugs from collection through final disposal.(g) Ordinance Repeal. Pursuant to subdivision (e) of section 42032.2 of the Public Resources Code, description of processes, logistics, and timing of implementation that will be necessary for the stewardship program to expand into jurisdictions not previously included in the stewardship plan, in the event of the repeal of a local stewardship program ordinance. The description shall include an explanation of how the stewardship program will meet the convenience standards, pursuant to subsection (1)(F) of subdivision (a) of section 42032.2 of the Public Resources Code.(h) Safety and Security. Describe the general nature of any incidents with safety or security related to collection, transportation, or disposal of collected covered drugs. Explain what corrective actions were taken or will be taken to address the issue and improve safety and security. In addition, the following specific information about any incident(s) shall be made available to the department upon request, and shall include, but not be limited to: (2) Description of specific incident(3) Cause(s) of specific incident(5) Regulatory or law enforcement agencies involved and any litigation, arbitration, or other legal proceedings that result from each incident(i) Education and Outreach. Description and evaluation of the comprehensive education and outreach activities pursuant to section 18973.2(j), including, but not limited to, the following: (1) Electronic examples of promotional marketing materials(2) Numerical results of the education and outreach metrics outlined in the stewardship plan, pursuant to section 18973.2(j)(5)(3) A discussion of what the metrics, described above in section 18973.4(i)(2), reveal about the performance of the comprehensive education and outreach program, including, but not limited to, ultimate user awareness, program usage, and accessibility(4) Description of how the requirement of section 42031.6(b) of the Public Resources Code was met.(j) Covered Entities, Covered Products, and Authorized Collectors. List of the following: (1) Participating covered entities covered by the stewardship plan and their contact information including, but not limited to, the following: (A) Name of covered entity(B) Mailing and physical address(C) Contact name and title(2) A copy of the list of covered products submitted to the Board of Pharmacy pursuant to subsection (2) of subdivision (a) of section 42031 of the Public Resources Code.(3) Authorized collectors and their contact information including, but not limited to: (A) Name of authorized collector(B) Mailing and physical address(C) Contact name and title(k) Description and evaluation of the process for selecting service providers, if applicable.(l) Description of any grants, loans, sponsorships, reimbursements, or other incentives provided, as applicable.(m) Description of changes in staffing of the stewardship program.(n) A list of all actual expenses incurred during the previous reporting period. Expenses shall be summarized in accordance with the budget categories specified in section 18973.6(b).(o) Coordination Efforts. Description of how the program operator coordinated with other program operators to avoid confusion to the public and all program participants in the event that multiple stewardship programs for covered drugs are in operation concurrently or new stewardship programs begin operating.(p) State Agency Determinations pursuant to section 42032.2(a)(1)(C) of the Public Resources Code. Submit all agency determination(s) of compliance, noncompliance, and superseding determinations of compliance, if any, for the reporting period.Cal. Code Regs. Tit. 14, § 18973.4
1. New section filed 1-7-2021; operative 1-7-2021 (Register 2021, No. 2). Filing deadline specified in Government Code section 11349.3(a) extended 60 calendar days pursuant to Executive Order N-40-20 and an additional 60 calendar days pursuant to Executive Order N-71-20. Note: Authority cited: Sections 40401, 42031.2 and 40502, Public Resources Code. Reference: Sections 42030, 42031, 42031.6, 42032.2, 42033, 42033.2, 42033.4, 42033.6, 42034 and 42036.4, Public Resources Code; and Section 17041, California Code of Regulations.
1. New section filed 1-7-2021; operative 1/7/2021 (Register 2021, No. 2). Filing deadline specified in Government Code section 11349.3(a) extended 60 calendar days pursuant to Executive Order N-40-20 and an additional 60 calendar days pursuant to Executive Order N-71-20.